EARLY TOXICITIES AND ECONOMIC BURDEN OF CAR-T THERAPY IN THE UNITED STATES: A RETROSPECTIVE COHORT STUDY OF ICANS AND CRS USING OPTUM DATA
Author(s)
Vikash K. Verma, MBA, PharmD1, Louis Brooks Jr, MS2, Marissa Seligman, PharmD3, Abhimanyu Roy, MBA4, Abhinav Nayyar, MBA, MBBS5, Ankitkumar Arora, MPharm6, Anuj Gupta, MSc7, Shakir Khan, MBA8, Anjali Dixit, PhD9, Vishan Khatavkar, MBA10, Shakilur Rahman, Other11, Archana Arya, MBA12, Atish C. Musle, MBA13, Ruchi Singhal, PhD14;
1Optum Lifesciences, Boston, MA, USA, 2Optum, Bloomsbury, NJ, USA, 3Optum, Winchester, MA, USA, 4Optum, Gurgaon, India, 5Optum Life Sciences, Gurugram, India, 6Optum Global Solutions, Gurgaon, India, 7Optum Lifesciences, Noida, India, 8Optum, United Health Group, Hyderabad, India, 9Optum, Noida, India, 10Optum Lifesciences, Gurugram, India, 11Optum Global Solutions, Noida, India, 12Optum Global Solutions, Haryana, India, 13Optum, Gurugram, India, 14Optum Global Solution, Gurgaon, India
1Optum Lifesciences, Boston, MA, USA, 2Optum, Bloomsbury, NJ, USA, 3Optum, Winchester, MA, USA, 4Optum, Gurgaon, India, 5Optum Life Sciences, Gurugram, India, 6Optum Global Solutions, Gurgaon, India, 7Optum Lifesciences, Noida, India, 8Optum, United Health Group, Hyderabad, India, 9Optum, Noida, India, 10Optum Lifesciences, Gurugram, India, 11Optum Global Solutions, Noida, India, 12Optum Global Solutions, Haryana, India, 13Optum, Gurugram, India, 14Optum Global Solution, Gurgaon, India
OBJECTIVES: Chimeric antigen receptor T‑cell (CAR‑T) therapies have transformed outcomes for patients with hematologic malignancies but carry substantial risks of early toxicities, notably cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). This study evaluated the real‑world incidence, severity, timing, and economic burden of CRS and ICANS among US CAR‑T recipients.
METHODS: A retrospective cohort study was conducted using Optum® Market Clarity data (January 2018-June 2025). Adults receiving any FDA‑approved CAR‑T therapy (Axi‑cel, Tisa‑cel, Brexu‑cel, Liso‑cel, Ide‑cel, Cilta‑cel) were included. The index date was defined as the first CAR‑T infusion. Eligibility required ≥6 months pre‑index and ≥3 months post‑index continuous enrollment; patients undergoing stem cell transplantation within 90 days pre‑index were excluded. CRS and ICANS events were identified and graded (ASTCT Grade 1-4) using diagnostic coding and clinical indicators. Economic outcomes included CAR‑T episode costs, toxicity‑related costs, and all‑cause healthcare resource utilization (HCRU).
RESULTS: Among 1,243 CAR‑T recipients, CRS occurred in 29% of patients (Grade ≥2: 13%; Grade ≥3: 2%) and ICANS in 11% (Grade ≥2: 7%; Grade ≥3: 5%). Median onset was rapid—4.1 days for CRS and 3.2 days for ICANS—with events beyond day 14 uncommon. The median CAR‑T therapy cost was $251,438 (IQR $250,007-$256,658). Total all‑cause post‑infusion costs reached $172,544, driven primarily by inpatient care ($43,471) and outpatient services ($7,135). Toxicity‑related costs were substantial (median $62,126; IQR $31,447-$118,809), with inpatient management accounting for the majority of expenditures (median $57,059; IQR $27,833-$109,830).
CONCLUSIONS: Early‑onset CRS and ICANS were common and required intensive inpatient management, contributing significantly to the total economic burden of CAR‑T therapy. These findings underscore the need for optimized toxicity prevention, early detection, and supportive‑care pathways to reduce avoidable utilization and improve both clinical and economic outcomes.
METHODS: A retrospective cohort study was conducted using Optum® Market Clarity data (January 2018-June 2025). Adults receiving any FDA‑approved CAR‑T therapy (Axi‑cel, Tisa‑cel, Brexu‑cel, Liso‑cel, Ide‑cel, Cilta‑cel) were included. The index date was defined as the first CAR‑T infusion. Eligibility required ≥6 months pre‑index and ≥3 months post‑index continuous enrollment; patients undergoing stem cell transplantation within 90 days pre‑index were excluded. CRS and ICANS events were identified and graded (ASTCT Grade 1-4) using diagnostic coding and clinical indicators. Economic outcomes included CAR‑T episode costs, toxicity‑related costs, and all‑cause healthcare resource utilization (HCRU).
RESULTS: Among 1,243 CAR‑T recipients, CRS occurred in 29% of patients (Grade ≥2: 13%; Grade ≥3: 2%) and ICANS in 11% (Grade ≥2: 7%; Grade ≥3: 5%). Median onset was rapid—4.1 days for CRS and 3.2 days for ICANS—with events beyond day 14 uncommon. The median CAR‑T therapy cost was $251,438 (IQR $250,007-$256,658). Total all‑cause post‑infusion costs reached $172,544, driven primarily by inpatient care ($43,471) and outpatient services ($7,135). Toxicity‑related costs were substantial (median $62,126; IQR $31,447-$118,809), with inpatient management accounting for the majority of expenditures (median $57,059; IQR $27,833-$109,830).
CONCLUSIONS: Early‑onset CRS and ICANS were common and required intensive inpatient management, contributing significantly to the total economic burden of CAR‑T therapy. These findings underscore the need for optimized toxicity prevention, early detection, and supportive‑care pathways to reduce avoidable utilization and improve both clinical and economic outcomes.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE40
Topic
Economic Evaluation
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
SDC: Oncology